[sugar-sur] [IAEP] Sugar network / School Network

[Chris Leonard]

On Tue, May 17, 2016 at 10:31 AM, Dave Crossland <dave at lab6.com> wrote:
>
> On 17 May 2016 at 10:17, Chris Leonard <cjlhomeaddress at gmail.com> wrote:
>>
>> Source of funding has nothing to do with the applicability of laws and
>> regulations on human subjects protection in research.
>
>
> Please explain this.
>
> Laws are one thing, regulations are another; laws apply to everyone in a
> jurisdiction, regulations are self-applied by organizations.
>
> The HHS regulations page says in its first paragraph that it applies to
> research institutions that have DHHS funding.
>
> The HHS website about page says:
>
> The Office for Human Research Protections (OHRP) provides leadership in the
> protection of the rights, welfare, and wellbeing of subjects involved in
> research conducted or supported by the U.S. Department of Health and Human
> Services.
>
>
> Sugar Labs is not a research institute and doesn't have DHHS funding, so
> these regulations do not apply; they are merely useful reference material.


IANAL, but I'm not sure that HHS would necessarily be the appropriate
regulator of relevance, but "official" positions on any form of human
subjects research are largely standardized by international
conventions and foundational documents like the Nuremburg Code and the
Helsinki Declaration.  My citation of my own experience in conducting
and overseeing *biomedical* human subjects research was merely a
cautionary statement by analogy, not a reference to being fully
up-to-date on applicable law governing educational research.

If I had to guess, and it would only be a guess, I would think the US
Department of Education would be a potential regulator of the sort of
activities that someone associated with Sugar Labs might consider
undertaking.  The US Department of Education also subscribes to and
enforces ethical principles derived from the commonly cited
foundational documents on ethical research, which by themselves do not
carry the force of law, but serve as the basis for most law-making in
the field of human subjects protection.

Unlike HHS, where the regulatory scope is primarily described in Title
21 of the Code of Federal Regulations (CFR), I believe the scope of
the Department of Education's regulatory remit is described within
Title 34 CFR, more specifically, part 97 (34CFR97 as it would be
commonly cited.)

http://www2.ed.gov/policy/fund/reg/humansub/part97-2.html#97.101

In reading these documents, one will typically see very specific
callouts saying that they apply to federal government employees, etc.
to make clear that the Congress does not intend to allow appeals to
the general concept of sovereign immunity for activities by the
federal government, or doing what Congress often does, exempting
itself from the need to comply with a specific law.  The purpose of
these call-outs are generally to make the coverage of the law broader
by specifically saying they do apply to Feds, contractors and funding
recipients, rather than narrower.  One should never read the CFR and
make a determination that it "does not apply to me" without consulting
with a lawyer.  That way lies madness as well as potential fines and
imprisonment.

Even in the statements that seem to specifically exempt a particular
area, one finds weasel words like "unless otherwise required by
department or agency heads" without real guidance as to whether your
particular situation falls within the scope of the law or not.  It is
generally safer to read such arcane legal documents with an eye
towards "how might this be construed to apply to me" than with an eye
towards "how can I argue on an e-mail list that this does not apply to
me".  Arguments on an e-mail list and those conducted in the federal
or other jurisdictional courts bear little resemblance to each other,
much to the chagrin of those who run afoul of laws they thought "did
not apply to them".

34CFR97.101c through 34CFR97.101h provide ample examples of the sorts
of legalese that is intended to disabuse you of the notion that any
given activity is not covered by this or similar laws in some other
jurisdiction.  Going to an e-mail list for legal advice is a fool's
errand, you need to consult with a lawyer if you want to gather data
on human people (various data privacy laws MAY apply) and especially
children (various human subject and informed consent laws MAY be
applicable).  Assuming that there are not applicable laws (or
regulations granting a particular Federal agency regulatory or
enforcement powers) governing an activity like collecting data on how
kids use computers in an educational setting is a generally bad idea,
YMMV,

IANAL, so I will not venture opinions as to whether the relevant law
under which a given Federal agency has been granted regulatory
authority (by any given CFR Title or part)  is FERPA (Family
Educational Rights and Privacy Act) or some other bit of statute, that
is what lawyers get paid to do and IANAL.

cjl